Derma Sciences : Continued Healing at 24 Weeks in Patients with Diabetic Foot Ulcers Treated with DSC127 in Phase 2 Trial

May 25, 2011 - Healing spread widens between DSC127 0.03% group and placebo group compared with 12-week data - Wounds up to five times more likely to heal at 24 weeks with DSC127 0.03% versus placebo - Derma Sciences, Inc. (Nasdaq: DSCI), a medical device and pharmaceutical company focused on advanced wound care, announced that in the follow-up portion of its Phase 2 clinical trial in patients with diabetic foot ulcers, the percentage of patients treated with the therapeutic (0.03%) dose of DSC127 with complete healing at 24 weeks following trial enrollment was 73% in the intent-to-treat (ITT) population and 85% in the per-protocol population (PP), a difference of 27 and 33 percentage points, respectively, compared with patients treated with placebo/standard of care (placebo). DSC127 is a patented, topically applied novel angiotensin analog that targets receptors that are up-regulated upon injury to tissue.

Healing was defined as 100% epithelialized with no drainage. The Company previously announced that the 0.03% dose of DSC127 exceeded the trial's goal of an improvement of 15 percentage points in complete healing of wounds at 12 weeks for both the ITT (21 percentage point increase) and PP (27 percentage point increase) populations, compared with placebo. With today's announcement, the improvement at 24 weeks between patients treated with DSC127 0.03% and patients treated with placebo is even more pronounced. There were no drug-related adverse safety events during the entire 24-week study period.

The double-blind, placebo-controlled, multi-center Phase 2 clinical trial randomized 80 patients to receive one of two dose strengths of DSC127 (0.03% or 0.01%) or vehicle placebo control. After 14 days of best standard-of-care to evaluate ulcer healing and ensure the wounds were chronic, those patients randomized into the study received four weeks of active treatment followed by eight weeks of observation and assessment. Although the primary endpoint of the trial was healing at 12 weeks, patients continued to be followed for an additional 12 weeks to gain further information on the drug and its effects. Consistent with what was seen at week 12, the 0.01% dose of DSC127 continued to be comparable to placebo at week 24, and therefore non-therapeutic. The table below shows the percentage of patients healed at weeks 12 and 24, with the 0.03% dose of DSC127 and placebo... Derma Sciences' Press Release -

Metabolic Solutions Development : Launches Phase 2a Trial of its Second Compound to Treat Type 2 Diabetes

March 29, 2011 – Metabolic Solutions Development Company (MSDC), a drug discovery and development company exploiting novel molecular targets to treat metabolic diseases, announced that it has launched a Phase 2a trial for MSDC-0602, the company’s second drug candidate for the treatment of type 2 diabetes. The 28-day, randomized, double-blind, comparator- and placebo-controlled clinical trial will involve approximately 125 patients at 15 planned sites throughout the United States.
MSDC-0602 is a selective modulator of mitochondrial metabolism that modifies nutrient-sensing pathways leading to improved insulin action without direct activation of nuclear transcription factors. “Because this novel mechanism of action does not depend on direct activation of nuclear transcription factors, type 2 diabetic patients treated with MSDC-0602 are not expected to experience fluid retention or weight gain as do patients treated with the currently marketed PPARγ agonists,” said Dr. Jerry Colca, president and chief scientific officer of MSDC.
In addition to gathering additional safety and tolerability data, the Phase 2a trial will evaluate the reduction in fasting plasma glucose following once-daily dosing for 28 consecutive days in patients with type 2 diabetes. Patients taking MSDC-0602 will be compared to those taking 45 mg of pioglitazone and placebo... [PDF] Metabolic Solutions Development's Press Release -

Stempeutics Research : DCGI nod to start Phase II clinical trial...

January 20 th, 2011 – Stempeutics Research a group company of Manipal Education & Medical Group announced that Drug Controller General of India (DCGI) has granted clearance of the company’s Investigational Medicinal Product “Stempeucel” for conducting Phase II clinical trials in patients with Osteo Arthritis, Diabetes Mellitus – Type 2, Liver Cirrhosis and Chronic Obstructive Pulmonary Disease. Stempeucel product is developed from allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. Earlier the company has received approval from DCGI for Phase I/II clinical trial for Acute Myocardial Infarction and Critical Limb Ischemia in March 2009. Stempeutics is funded by Manipal Group and Cipla...


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Diabetes Mellitus – Type2

Diabetes mellitus Type2 is a disease in which a person has high blood sugar, either because the body does not produce enough insulin, or because cells do not respond to the insulin that is produced. Current therapies for diabetes include oral hypoglycaemic drugs and insulin injections in addition to dietary management. They do not address the root cause i.e. lack of functional cells in pancreas and peripheral insulin resistance. This study is planned to see if stem cells injected into patients with diabetes, can trigger pancreatic resident stem cells / progenitors to form new cells. If successful, stem cell therapy possibly may result in permanent cure for diabetes. The objective of this study is to evaluate the safety and efficacy of a single intravenous dose of “Stempeucel” in type 2 diabetes mellitus and to find out the most suitable dose of stem cells... [PDF] Stempeutics Research's Press Release -

Asante Solutions : CE Mark for Pearl™ Insulin Pump

April 12, 2011 – Asante Solutions, Inc. (Asante), a medical device company focused on diabetes care, announced it received the CE mark for its Pearl Insulin Pump, the only insulin pump that uses a pre-filled insulin cartridge. The CE mark is a European proof of conformity that certifies the product meets EU safety, health and environmental requirements. Asante has begun discussions with potential distribution partners in Europe.
“This important regulatory milestone brings us one step closer to our goal of delivering a sensible solution to the growing but underserved insulin pump market,” said Phil Hopper, Asante CEO and President. “Once available, we believe the small and sleek Pearl will be the simplest-to-operate pump on the market. The Pearl is a fully featured insulin pump addressing the imperatives of safety, reliability, and ease of use required to meet the needs of people with diabetes using intensive insulin therapy.”

The Pearl Insulin Pump is designed to simplify diabetes care for the more than 500,000 people worldwide who use an insulin pump and those considering insulin pump therapy. Unlike the insulin pumps currently available, which require users to manually fill an insulin reservoir using a vial of insulin and syringe, the Pearl Insulin Pump uses a 300-unit, pre-filled insulin cartridge that simplifies the process of loading the pump and filling the infusion set by reducing the number of steps required and thereby creating a less time-consuming and more convenient process... [PDF] Asante Solutions' Press Release -

Diartis Pharmaceuticals : New Biotech Company Will Focus on Clinical Development of Novel Diabetes Drug

February 16, 2011 - INDEX VENTURES AND AMUNIX INVEST IN DIARTIS PHARMACEUTICALS – Diartis Pharmaceuticals, Inc., a newly founded biotechnology company, announced that it has received initial funding from Index Ventures, Amunix Inc., a U.S. based biotechnology company, and private investors. The company has also acquired a clinical-stage diabetes drug candidate from Versartis, Inc., VRS-859 (exenatide-XTEN), and with this initial funding will continue its development for type 2 diabetes mellitus (T2DM).

A Phase 1a multi-center, blinded, placebo-controlled, single-ascending dose study is ongoing to evaluate the safety and ability of VRS-859 to maintain glycemic control for one month in T2DM patients after a single dose. The results of the Phase 1a study are anticipated in Q2 2011. The Phase 1a study will be followed later this year by a repeat dose (3 month) Phase 1b study comparing VRS-859 to Byetta® (exenatide injection) in T2DM patients. VRS-859 is intended as a once-monthly form of the GLP-1 analog, exenatide.

Commenting on the investment, Kevin Johnson, London based partner at Index Ventures said, “We are delighted to invest in Diartis Pharmaceuticals Pharmaceuticals. The company will focus on moving this exciting compound rapidly through early clinical development. Given the dramatic rise in the number of people with type 2 diabetes, there is a significant market need for a longer acting form of the GLP-1 analog exenatide.”... Diartis Pharmaceuticals' Press Release -

Genentech : Second Lucentis Phase III Study Meets Primary Endpoint for Improved Vision in Patients with Diabetic Macular Edema (DME)

March 25, 2011 - -- Results Consistent with Data Released Last Month Showing Patients with DME Who Received Lucentis Achieved Significant Improvement in Vision - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the second of two Phase III trials evaluating Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME) met its primary endpoint. The primary endpoint of the study, known as RIDE, showed that after 24 months a significantly greater number of patients who received Lucentis, compared to those who received placebo (sham) injections, were able to read at least 15 additional letters on an eye chart than they could at the start of the study. The safety results were consistent with previous Lucentis Phase III trials and no new significant safety findings were observed. Further analyses of the data are ongoing. Topline results from the RIDE study will be presented at the EURETINA Congress in London on May 29, 2011.

DME is an eye condition characterized by swelling of the retina, which can occur in patients with type 1 or type 2 diabetes and can cause blurred vision, severe vision loss and blindness.1 DME is a leading cause of blindness among the working-age population in most developed countries,2 and there are currently no U.S. Food & Drug Administration (FDA) approved medications to treat DME.
"This data adds to the considerable body of clinical evidence showing that patients with DME who received Lucentis had significant improvement in vision," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Lucentis may provide physicians and patients with a potential option for DME, and we look forward to sharing the data from this study and a previous Phase III trial with the FDA and medical community."... Genentech's Press Release -

Mylan Pharmaceuticals : Approval for Generic Version of Precose® Tablets

Jan. 18, 2011 -- Mylan Inc. (Nasdaq: MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Acarbose Tablets, 25 mg, 50 mg and 100 mg, the generic version of Bayer's Precose® Tablets, a treatment to be used with diet and exercise to improve glycemic control in adults with type 2 diabetes.

Acarbose Tablets had U.S. sales of approximately $23 million for the 12 months ending Sept. 30, 2010, according to IMS Health. The product is available for immediate shipment.

Currently, Mylan has 169 ANDAs pending FDA approval representing $99.5 billion in annual sales, according to IMS Health. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $24 billion in annual brand sales, for the 12 months ending June 30, 2010, according to IMS Health... Mylan's Press Release -

Biocrates Life Sciences : Metabolomic biomarker research for the early detection of diabetes

13 January 2011 – Metabolomic biomarker research is a young research area that carries great hopes for both medicine and the nutritional sciences, particularly for the early detection of genetically determined diseases. [...] The Austrian biotech company BIOCRATES Life Sciences AG provides cutting-edge support to these new research areas by contributing valuable research results, making available state-of-the-art research products, and setting milestones in the early detection of diabetes and in the field of personalized medicine.
Metabolomics - a young research field
The metabolome is the entirety of metabolites of an organism. This full set of metabolites is a mirror of the metabolic state of a cell or tissue. Metabolomics allows the medical profile of an individual to be determined, thereby predicting disease risk or how the organism will react to a particular drug. “Research into the metabolome can provide important insights into diseases such as cancer, nervous system disorders, asthma, or diabetes,” says Professor Jerzy Adamski, Helmholtz Center Munich. “Metabolomics enables the risks of certain diseases to be predicted and new diagnostic and therapeutic procedures to be developed. By analyzing the interactions between the genome (i.e., the entirety of the hereditary information of an organism), the metabolome, and environmental conditions, preventive health measures can be devised.”... [PDF] Biocrates Life Sciences' Press Release -

NeuroMetrix Announces New Strategic Direction : Primary Focus on Diabetes

Jan 04, 2011 - NeuroMetrix, Inc. (Nasdaq: NURO) announced that it will shift its business focus to diabetes, specifically detection and monitoring of diabetic neuropathy which is a common complication of the disease. The Company will continue to support its neurodiagnostic business which it intends to manage to optimize cash flow.

"Diabetes represents the largest and fastest growing opportunity for our proprietary technology," said Shai N. Gozani M.D., PhD., President and Chief Executive Officer of NeuroMetrix. "This is a fast growing sector in health care as countries around the world struggle to cope with an epidemic of Type II diabetes. Neuropathy is a common and serious complication of the disease that may lead to foot ulcers and limb amputation. We have over a decade of experience in neuropathy detection and believe we are uniquely positioned to address the unmet need for a rapid, cost-effective, objective test for diabetic neuropathy. We are working towards a mid 2011 launch of NC-stat-SL, which is a modified version of our NC-stat device designed specifically for assessment of diabetic neuropathy at the point-of-care. In support of our efforts, we have assembled a scientific advisory board of international experts."... NeuroMetrix's Press Release -

Sanofi-aventis Acquires from Ascendis Pharma Worldwide Rights on Drug-Delivery Technology in Diabetes and Related Disorders

December 21, 2010 – Innovative technology designed for sustained release of peptides and proteins – Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) and Ascendis Pharma (Ascendis) announced a global licensing and patent transfer agreement on Ascendis’ proprietary TransCon Linker and Hydrogel carrier technology, which allows for a drug compound to be released in the body in a precise, time-controlled fashion, creating a long-acting effect.
The technology creates transient bonds between larger molecules such as proteins and peptides, including insulin, and a carrier. This allows for tailor-made release profiles, with no initial burst and high drug load formulations. The TransCon Linker technology has shown promising results in preclinical studies in delivering insulin.

“We are excited about this promising technology to create next-generation products in the field of diabetes and related disorders,” commented Pierre Chancel, Senior Vice-President, Head of the Global Diabetes Division, sanofi-aventis. “Building on our achievements with Lantus®, our 24-hour insulin approved for use once a day, we hope to further improve the lives of people with diabetes by developing this innovative technology to offer biologicals that present an extended and controlled release of unmodified parent drugs, including insulin."... [PDF] Ascendis Pharma's Press Release - [PDF] Sanofi-aventis' Press Release -

Evotec : Metabolic disease alliance with MedImmune

15 December 2010 - Focus on innovative diabetes therapy - €5 million upfront payment, up to €254 million milestones and royalties - Evotec's first commercial agreement in the field of beta cell regeneration - Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX) announced that via its subsidiary Develogen AG it has entered into a license and collaboration agreement with MedImmune (the global biologics unit of AstraZeneca), in the diabetes therapeutic area, with a particular focus on the regeneration of insulin producing beta cells. The license gives MedImmune exclusive access to a portfolio of research programs and represents the first deal executed by Evotec on beta cell regeneration assets and capabilities.


The agreement triggers an upfront payment of € 5 million. Further on, additional deferred payments including potential milestone payments of up to € 254 million as well as royalties are agreed. The milestone payments will be due upon achievement of certain clinical as well as regulatory and commercial events.


Further milestone payments may be achieved with the approval of additional indications and programs. Evotec will also receive research payments to support further in vivo and in vitro pharmacology efforts conducted in collaboration with MedImmune... Evotec's Press Release -